BioPorto (NASDAQ COPENHAG:BIOPOR) A/S announced it had reached its target subject enrollment for the final part of a three-part clinical study on The NGAL Test to patients under the age of 22 at risk for Acute Kidney Injury (AKI).
The study will support a US Food and Drug Administration (FDA) De Novo submission for use of BioPorto (NASDAQ COPENHAG:BIOPOR)’s test.
“We are very pleased to have reached the study’s planned enrollment of 600 patients by the end of 2Q, as previously guided,” said Dr Christopher Bird, BioPorto’s chief medical officer. We are now reviewing the clinical data to confirm that no additional data is required, after which we will perform an in-depth data analysis, complete the other required technical and analytical material, and submit the application to the FDA for De Novo approval.”
READ: BioPorto announces appointment of pediatric nephrology specialist Dr Prasad Devarajan as senior medical director effective July 1
The NGAL Test is designed to aid in the risk assessment of AKI, a common clinical syndrome that can have severe consequences, including significant morbidity and mortality if not identified and treated early. The test allows physicians to identify patients potentially at risk of AKI more rapidly than is possible with current standard of care measurements, enabling earlier intervention and more tailored patient management strategies.
The NGAL Test was granted Breakthrough Device designation by the FDA for expedited review.
BioPorto said it expects submission of its De Novo application to the FDA by the fourth quarter of 2022, based on the quality of the clinical data and other material to support the desired claims.
CEO Tony Pare told shareholders that achieving targeted enrollment is a “major milestone” in the company’s commercialization strategy.
“I am very proud of how our team and clinical partners sustained momentum during the pandemic and executed according to the plan we established,” Pare said in a statement.
“We are now directing the bulk of our energy into finalizing and submitting the application to the FDA and preparing to make the test available to clinicians so they may better tailor care of critical ill patients.”
Copenhagen- and Boston-based BioPorto is an in vitro diagnostics company focused on saving lives and improving the quality of life with actionable biomarkers.
Contact Angela at angela@proactiveinvestors.com
Follow her on Twitter @AHarmantas